非公開
• Local legal entity registration
• Transfer ownership of existing product licenses from the current company to new one, per project plans
• Submit and gain approval for company name change for all products, per project plans
• Complete all activities to gain new product approvals and product changes:
o Identify reportability for changes and regulatory strategy for new products
o Prepare new product or product change submissions, based on EU or US product submission materials
o PMDA advisory meetings
o Manage deficiency responses, working with legal manufacturer
o Communicate updates with legal manufacturer
• Ensure proper IFU and product labels
• Review and approve promotional material
• Provide regulatory guidance on over-labeling by local office
• Ensure license renewals and maintain license documentation
• Support MDSAP audit preparation by collecting documents and responding to questions
• Monitor and communicate changes in local regulations and impact
• Availability for twice/month meetings, aligned with EU time
急成長中のグローバル薬事、品質コンサルティング企業です。